an open label dose titration of sevelamer carbonate tabs 3 times a day in hyperphosphatemic ckd patients not on dialysis

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Summary: approximately 45 hyperphosphatemic ckd patients not on dialysis will be entered into this study at approximately 20 sites within europe and 5-10 in australia. the purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (tid) is an effective treatment for the control of serum phosphorous levels in hyperphosphatemic ckd patients not on dialysis. total length of participation is approximately 14 weeks.


Eligibility criteria:
inclusion criteria: * a minimum of 120 male and female patients with chronic kidney disease not requiring dialysis will be screened for participation in the study. * men or woman 18 years of age or older * if currently taking phosphate binder(s), willing to stop this and enter a 2 week washout period * willing to avoid any intentional changes in diet such as fasting or dieting * have the following central laboratory measurements: 1. if not on a phosphate binder, a serum phosphorus measurement ≥ 5.5 mg/dl (1.76 mmol/l) at screening (visit1). 2. if taking a phosphate binder(s) at screening, a serum phosphorus measurement ≥ 5.5 mg/dl (1.76 mmol/l) after the two-week washout period at visit 1a (day 0). * at screening (visit 1), have the following central laboratory measurements: 1. 25-hydroxyvitamin d ≥ 10 ng/ml 2. ipth ≤ 800 pg/ml * willing and able to take sevelamer carbonate alone as a phosphate binder for the duration of the study * willing and able to maintain screening doses of lipid medication, 1,25 dihydroxyvitamin d, and/or cinacalcet for the duration of the study, except for safety reasons * willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement * if female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or iuds * expecting not to initiate dialysis for the duration of this study * considered compliant with phosphate binders (if applicable) * willing and able to provide informed consent * has not participated in any other investigational drug studies within 30 days prior to enrollment, * level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel exclusion criteria: * active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (gi) motility disorders * active ethanol or drug abuse, excluding tobacco use * use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders. * in the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, hiv infection, or any clinically significant unstable medical condition * pregnant or breast-feeding * evidence of active malignancy except for basal cell carcinoma of the skin * unable to comply with the requirements of the study * known hypersensitivity to sevelamer or any constituents of the study drug * any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study